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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K051073
Device Name MIDIVIEW SERIES OF MICROENDOSCOPES
Applicant
Millennium Devices, Inc.
250 Gibbs Rd.
Islandia,  NY  11749
Applicant Contact JOSEPH LIBRIZZI
Correspondent
Millennium Devices, Inc.
250 Gibbs Rd.
Islandia,  NY  11749
Correspondent Contact JOSEPH LIBRIZZI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/26/2005
Decision Date 05/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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